DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Receipt is acknowledged for IDS filed 01/28/2025 and preliminary amendment filed 01/07/2026.
Claims 3, 15, 18, 23, 25-37, 39, 41-42 and 44-53 are canceled.
Claims 4-5, 19, 21-22, 24, 38, 40, 43 and 54-55 are amended.
Claims 1-2, 4-14, 16-17, 19-22, 24, 38, 40, 43 and 54-57 are pending.
Priority
This application is a 371 of PCT/US2023/029031 filed 07/28/2023 and which claims benefit of 63/369,690 filed 07/28/2022.
Information Disclosure Statement
The IDS filed 01/28/2025 has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 8 and 43 and 54 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2, 8 and 43 use “e.g” (example) to further limit a broad category to a narrower category of products within the same claim. The use of “e.g.” confuses the scope of the claims making it unclear if the narrower range is a limitation.
Claim 54 is a method claim that depends on claim 1, which is a composition claims. Thus, it is not clear how a method claim depends on a composition claim. Claim 54 is examined as the composition of claim 1, ….
Correction is respectfully requested.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4, 6-14, 16-17, 19, 21-22, 38, 43 and 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garigapati et al., (US 20160279281 A1).
Claim 1 is an adhesive composition comprising, i) multivalent metal salt, ii) multidentate acidic organic compound, iii) porogen, and iv) an aqueous medium. Claim 1 further states that, the composition has a porosity between about 10% to about 50% upon curing. This wherein clause implicates that a prior art adhesive composition comprising i) multivalent metal salt, ii) multidentate acidic organic compound, iii) porogen, and iv) an aqueous medium would also have a porosity of between about 10% to about 50% upon curing.
For claims 1-2, Garigapati discloses adhesive interpenetrating network composition (see the whole document with emphasis on the title) comprising amino acid phosphate multivalent compound having the formula:
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which is the multidentate compound of claim 1, the multidentate compound of claim 9 and the phosphoserine multidentate compound of claim 10; multivalent metal compound, aqueous environment meeting the requirement for aqueous medium (see at least paragraphs [000], [0008], [0015]). Phosphoserine is one of the compounds of the formula above when A is Oxygen (O), n is 1, and R is NH2.
The composition also contains additives namely calcium carbonate that enhances porosity properties of the materials (paragraphs [0035], [0037], [0038]). The composition is cured and Garigapati teaches the level of porosity developed during the curing process is influenced by pore forming additives namely calcium carbonate additive and a porosity of up to 60% is contemplated (paragraph [0038]). Calcium carbonate meets the limitation of porogen of claim 1 and calcium carbonate porogen of claim 2.
While Garigapati teaches that porosity of up to 60% is contemplated, Garigapati differs from claim 1 by not teaching the porosity range of between 10% to about 50%. However, up to 60% encompasses/includes 10% up to 50%. Therefore, it would have been prima obvious to the ordinary skilled artisan before the effective date of the invention that the porosity of the cured adhesive composition of Garigapati would predictably include porosity between about 10% and 50% because up to 60% includes 10 % up to 50%.
For claim 2, the pore forming/porogen calcium carbonate meets the claim.
For claim 4, Garigapati teaches pore sizes of from about 20-500 mm or 50-125 mm (paragraph [0036]) with the narrower range of 50-125 mm being specific point range within the claimed range of 20-200 mm.
For claim 6, Garigapati teaches that the pH of the environment/milieu in which the interpenetrating network is formed is above pH of 5 and 6 but below pH of 9 (paragraph [0034]). Therefore, before the effective date of the invention the ordinary skilled artisan would reasonably expect the pH of the aqueous environment/milieu to be predictably below 9 including below 8.5 with the expectation that permanent bonds form in the interpenetrating networks.
For claim 7, Garigapati teaches that the composition is tacky shortly after mixing (paragraphs [0021], [0043]) and since Garigapati teaches that the pH after mixing is below pH of 9 but above pH of 5 and 6 (paragraph [0034]), it will be reasonable to expect that the pH of the tacky state is greater than 6 and less than 9 which includes a range of less than 9 and greater than 6 rendering the claimed range of between 7 and 10 prima facie obvious.
Foer claim 8, the multivalent compound are tetracalcium phosphate (TTCP), calcium phosphate and tricalcium phosphate (paragraphs [0015]-[0017], claim 36) meeting the claim.
For claims 9 and 10, phosphoserine (claims 34, 35, at least paragraphs [p009], [0010], [0025]) teach these claims.
For claim 11, the amino acid phosphate multidentate compound/species is present at about 10% to about 89.9% which teaches the claimed range of between 10% and 90%.
For claim 12, the aqueous environment including water, saline, plasma, serum, whole blood (paragraph [0030]) meet the limitation of the claim.
For claims 13 and 14, Garigapati’s composition further comprises additives such as polyols, PEG, biodegradable polymers, pigment or dye (paragraph [0035], [0037], [0040], [0041], [0042, [0049]) teaching claims 13 and 14.
For claim 16, Garigapati teaches that the tacky state within the first 2 and 4 minutes after mixing have strength of 10 kPa to about 250 kPa (paragraph [0021]).
For claim 17, the amino phosphate species is in powder from (paragraph [0030]), tricalcium phosphate multidentate acidic compound is in powder form (paragraph [0037]) and calcium carbonate pore forming agent (porogen) is in powder form (Table 1, paragraph [0060]).
For claims 19, 38 and 54, Garigapati teaches pore sizes of from about 20-500 mm or 50-125 mm (paragraph [0036]) with the ranges 20-500 mm and 50-125 mm being specific point ranges within the claimed range of 0.01 mm to 1.0 mm (10-1000 mm).
For claims 21 and 22, Garigapati prepares the adhesive interpenetrating network composition by mixing amino acid phosphate multivalent compound:
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, multivalent metal compound, aqueous environment/medium including water, saline, plasma, serum, whole blood (paragraph [0030]), additives namely calcium carbonate that enhances porosity properties of the materials (paragraphs [0035], [0037], [0038]), and curing the mixture such that porosity of up to 60% is achieved (paragraph [0038]). Garigapati teaches that the pH of the environment/milieu in which the interpenetrating network is formed is above pH of 5 and 6 but below pH of 9 (paragraph [0034]). Garigapati teaches that shortly after mixing (paragraphs [0021], [0043]) a pH below 9 but above pH of 5 and 6 (paragraph [0034]) is achieved. Garigapati does not specifically teach that the milieu/environment surrounding the adhesive interpenetrating is at a pH of less than 8.5. However, because the environment/milieu in which the interpenetrating network is formed is above pH of 5 and 6 but below pH of 9 (paragraph [0034]), before the effective date of the invention the ordinary skilled artisan would reasonably expect the pH of the aqueous environment/milieu to be predictably below 9 including below 8.5 with the expectation that permanent bonds form in the interpenetrating networks.
While Garigapati teaches that porosity of up to 60% is contemplated, Garigapati differs from claim 1 by not teaching the porosity range of between 10% to about 50%. However, up to 60% encompasses/includes 10% up to 50%. Therefore, it would have been prima obvious to the ordinary skilled artisan before the effective date of the invention that the porosity of the cured adhesive composition of Garigapati would predictably include porosity between about 10% and 50% because up to 60% includes 10 % up to 50%.
For claim 43, the tetracalcium phosphate and tricalcium phosphate of Garigapati (see at least paragraphs [0015]-[0017] teaches the claim.
Therefore, Garigapati renders claims 1-2, 4, 6-14, 16-17, 19, 21-22, 38, 43 and 54 prima facie obvious.
Claim(s) 1 and 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garigapati et al., (US 20160279281 A1), as applied to claim 1, in view of Lin et al., (US 20030078317 A1).
Garigapati has been described above to render claim 1 prima facie obvious. Claim 55 depends on claim 1. Garigapati does not teach that at least 10% of the multivalent metal salt have particle sizes below 45 mm. However, it is known in the art that tetracalcium phosphate (TTCP) particles have sizes that range from 0.05 mm to 100 mm and in one example, TTCP particle range in sizes from 1-11 mm (paragraphs [0016], [0025] of Lin). Therefore, before the effective date of the invention, the ordinary skilled artisan would reasonably expect at least 10% of the TTCP particles to fall within 0.05 mm to 100 mm or 1-11 mm and 1-11 mm being less than 45 mm.
Therefore, Garigapati in view Lin renders claim 55 prima facie obvious.
Claim(s) 1, 5, 21 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garigapati et al., (US 20160279281 A1), as applied to claims 1 and 21, in view of AHN et al., (US 20170312385 A1).
Garigapati has been described above to render claims 1 and 21 prima facie obvious. Claim 5 depends on claim 1. Claim 40 depends on claim 21.
Garigapati does not specifically disclose that the adhesive interpenetrating network composition has a density of about 0.75 to about 1.40 g/cm3 as required by claims 5 and 40. However, AHN discloses porous bone adhesive composition (paragraphs [0028], [0041]) comprising calcium salts including calcium carbonate (paragraph [0017]), wherein the adhesive composition has a density of 1-4 g/cm3 density (paragraph [0040]). Garigapati and AHN disclose porous bone adhesive compositions, comprising calcium salts including calcium carbonate. It would have been obvious to one having ordinary skill in the art to combine the teachings of Garigapati and AHN in order to design the adhesive interpenetrating network composition as disclosed in Garigapati, while maintaining the said composition density within the specified range, as disclosed in AHN, in order to enhance and better control properties of the said composition.
Thus, Garigapati in combination with AHN renders claims 5 and 40 prima facie obvious.
Claim(s) 1, 20, 21 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garigapati et al., (US 20160279281 A1), as applied to claims 1 and 21, in view of Wertz et al., (US 20030228981 A1).
Garigapati has been described above to render claims 1 and 21 prima facie obvious. Claim 20 depends on claim 1. Claim 24 depends on claim 21.
Garigapati does not specifically disclose adjusting the pH to basic pH with sodium hydroxide or basic pH adjusting agent. However, It is known in the art that sodium hydroxide, a basic pH adjusting agent is used to adjust the pH of composition to basic pH (see paragraph [0064] of Wertz). Therefore, before the effective date of the invention a person of ordinary skill in the art would reasonably expect that the pH of the composition of Garigapati would be adjusted predictably to basic pH with sodium hydroxide.
Therefore, Garigapati in combination with Wertz renders claims 20 and 24 prima facie obvious.
Claim(s) 1, 56 and 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garigapati et al., (US 20160279281 A1), as applied to claims 1, in view of NIVEN et al. (CA 2979471 C).
Garigapati has been described above to render claim 1 prima facie obvious. Claim 56 and 57 depend on claim 1. Garigapati does not teach the calcium carbonate porogen powder having the sies recited in claims 56 and 57. However, NIVEN nanocrystalline calcium carbonate having particle size of 59-120 nm improved hydration of cement mix (paragraph [00243]). Therefore, before the effective date of the invention, the artisan would have been motivated to use nanocrystalline calcium carbonate porogen in the composition of Garigapati with the expectation of predictably hydrating the product. 59-120 nm is a species of the claimed particle size range 0.000001 mm (1 nm) to 0.001 mm (1000 nm).
Therefore, Garigapati in view of NIVEN renders claims 56 and 57 prima facie obvious.
No claim is allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
